Press release 4 October 2021: Chemelot InSciTe research consortium reports successful start of 'first-in-man' clinical trial for novel scoliosis treatment
Maastricht, 4 October 2021 - A consortium of physicians and researchers from Maastricht UMC+, DSM Biomedical and Eindhoven University of Technology under the framework of translational research institute Chemelot InSciTe, announces that they have started the first-in-man clinical trial for a new scoliosis treatment within the project PoSTuRE (Patient Specific Scoliosis Treatment). The treatment consists of a newly developed GEM Power Cable, and tools for its implantation. This implant can reduce complications caused by the traditional surgical methods and instruments. The new treatment focuses primarily on improving the quality of life of patients with degenerative scoliosis by reducing the number of complications and reoperations resulting from it. The first patients have already successfully undergone surgery.
The clinical study is being conducted at the Maastricht UMC+ hospital. Over the next two years, fourteen adult patients over 50 years of age will be included in the study. The aim of this study is to demonstrate the safety and clinical effectiveness of the GEM-Power Cable System and technique. Patients will be followed over the course of five years and results will be published in due time. These patients come from the daily practice of orthopedic surgeon Paul Willems, also the project leader of the PoSTuRE consortium.
Many reoperations after complications of current scoliosis treatment
The idea for a new treatment came from problems encountered in daily clinical practice. After surgical correction of the spinal column, currently one third of adult scoliosis patients - two hundred per year in the Netherlands - end up on the operating table again due to complications. Deformities of the spine in adults are usually corrected by fixing the spine with rods, screws, and hooks. This type of rigid fixation surgery is not yet optimal and in some cases leads to complications such as screw pull-out and fracture of vertebrae at the transition segment from the rigidly fixed part of the spine to the mobile spine. Especially (older) patients with weaker bones as a result of osteoporosis have a high risk of complications. The re-operations that are necessary as a result are not only stressful for the patient, but also put a great strain on clinical care in terms of capacity and budget.
Advantages of the new technique
The new technique of PoSTuRE is used to replace or increase the screw fixation in some places of the conventional construct. The sublaminar cable, made from DSM Biomedical’s Dyneema Purity® Radiopaque fibers, is knotted around the vertebra and requires no drilling as with conventional screws. Dyneema Purity® is the strongest medical grade fiber in the world with 15+ years of clinical track record. The use of the Dyneema Purity® cable reduces the risk of screw break-out and improves the distribution of forces in the vertebra.
To help the surgeon fix the cable properly, the research consortium has also developed two supporting devices: a leader (blunt guiding needle) to guide the cable underneath the vertebral arch for fixation, and a 'tensioner' to tighten the cable.
The treatment could significantly improve patients' quality of life and could imply great social benefits, as it is expected to increase patient participation and significantly reduce the number of reoperations.
Multidisciplinary research consortium
Under the framework of translational research institute Chemelot InSciTe, a public-private partnership has worked for five years on the development of this new, more patient-friendly treatment. In valorizing the first proof of concept, doctors and researchers from Maastricht UMC+, DSM and Eindhoven University of Technology have been challenged to work across organizational boundaries, in a multidisciplinary and innovative manner. With success: The process from idea to clinical trial was quickly completed, the technology was protected through several patent applications and the research partners gained surprising new expertise through this open innovation platform.
Emiel Staring, Managing Director Chemelot InSciTe: ‘We are very proud to see that our unconventional biomedical collaborative innovation model has paid off and that we have been able to create a fast track to the clinic and to have paved the path from bench to bedside, also for future biomedical innovations to follow.’
Long-term value-adding research partners
The cooperation also adds sustainable value to the organizations of the project partners involved.
Paul Willems, Orthopedic surgeon and professor of Integrated Spinal Care at Maastricht UMC+: ‘In our hospital, we are now the first department responsible for setting up and running a 'first in man trial' with a concept we also co-developed . This is new for our hospital. So this project is instructive for us and the rest of the hospital. That is why we have also worked closely with our institute’s daughter Clinical Trial Center Maastricht (CTCM). They will soon be able to ensure that other departments can also benefit from the knowledge and network that we have built up.’
Koen Janssen, Vice President Innovation/R&D and Sustainability at DSM Biomedical: ‘DSM Biomedical is committed to solving our world’s healthcare needs through sustainable science. The multi-year commitment to the consortium in general and PoSTuRE in particular is evidence of that. We believe that our unique radiopaque Dyneema Purity® UHMWPE cable in combination with the other tools and surgical technique that we developed together in this project will have a major clinical and healthcare economic benefits in the treatment of degenerative scoliosis, which will ultimately benefit patients across the globe.’
Bert Rietbergen, Associate Professor in the Orthopedic Biomechanics group at Eindhoven University of Technology: ‘For us, this project was the ultimate practical example of successful collaboration by public and private parties. In this consortium, we have developed an innovative computer model that allows us to model the spine of each individual patient. This makes it possible to simulate a planned surgical correction in a predictive computer model so that patients can be helped optimally.’
Open innovation platform InSciTe
With the translational research institute Chemelot InSciTe, the Limburg region has an 'open innovation platform' of public and private parties jointly focusing on accelerated development and market readiness of biomedical materials. DSM, Maastricht University, Maastricht UMC+, Eindhoven University of Technology and the Province of Limburg are the initiators of this platform.
Since 2015, the institute has successfully acquired necessary knowledge and is now the linking pin in a network with more than 35 partners. InSciTe’s biomedical working model, with laboratories, equipment and expertise, makes it possible to create prototypes in unique test set-ups. The in-house expertise in Regulatory Affairs and Quality Assurance ensures that all the necessary knowledge to conduct clinical trials is available and benefits the project partners.
The combination of these factors accelerates the complex development process of medical technologies, making innovative medical products available for patients sooner. The resulting new products and services also lead to more business activity in Limburg and strengthen the region as a medical technology cluster.